Diagnosis of Celiac Disease after Starting Antitubercular Medication: A Case Report

We present the case of a young patient from Argentina living in a rural area without any relevant medical history. He consulted the emergency department after blunt chest trauma, and during trauma studies, images compatible with pulmonary tuberculosis were found, a diagnosis made incidentally. After starting treatment, he exhibited gastrointestinal symptoms such as diarrhea, abdominal pain, and weight loss, which were initially considered an adverse effect of treatment with rifampin/isoniazid/pyrazinamide/ethambutol (RHZE). Upon completing the first phase of treatment and suspending the medication, the symptoms improved, and the bacilloscopies were negative. Subsequently, the severity of the symptoms drew attention. Additional paraclinical tests were performed with malabsorptive diarrhea results, considering the patient's origin and the fact that his diet included products that he grew himself without prior exposure to gluten. Celiac disease is suspected, and antibodies and biopsy results compatible with this entity were obtained. When reviewing the association of symptom onset with the RHZE/pyridoxine treatment, we found these medications may have wheat-based excipients, which explains the worsening of symptoms, not due to the gastrointestinal adverse effects of the antibiotic but its excipients. Finally, the case was analyzed, tuberculosis was ruled out, and treatment was suspended, refocusing the therapeutic effort on recovering the patient's nutritional status. Subsequently, no other hospital admissions were recorded, and he remained respiratorily asymptomatic, with weight gain and nutritional recovery.

Se presenta el caso de un paciente joven, proveniente de Argentina y residente de un área rural, sin ningún antecedente médico a resaltar. Consultó al servicio de urgencias después de un trauma cerrado de tórax y durante los estudios de trauma se encontraron imágenes compatibles con tuberculosis pulmonar, diagnóstico realizado de manera incidental. Luego del inicio de tratamiento presentó síntomas gastrointestinales dados por diarrea, dolor abdominal y pérdida de peso, lo que inicialmente se consideró un efecto adverso al tratamiento con rifampicina/isoniazida/pirazinamida/etambutol (RHZE). Al completar la primera fase del tratamiento y suspender la medicación mejoraron los síntomas, además de que las baciloscopias fueron negativas. Posteriormente, llamó la atención la gravedad de los síntomas, por lo que se realizaron paraclínicos adicionales con resultados a favor de diarrea malabsortiva; teniendo en cuenta la procedencia del paciente y el hecho de que basaba su dieta en productos que él mismo cultivaba, sin haber exposición previa al gluten. Se sospecha enfermedad celíaca, y se obtuvieron anticuerpos y resultados en la biopsia compatibles con esta entidad. Al revisar la asociación de inicio de síntomas con el uso de tratamiento de RHZE/piridoxina, se observa que estos medicamentos pueden tener excipientes a base de trigo, lo que explica el empeoramiento de los síntomas, no por efectos adversos gastrointestinales del antibiótico sino por sus excipientes. Finalmente, se analizó el caso, se descartó tuberculosis y se suspendió el tratamiento, redirigiendo el esfuerzo terapéutico hacia la recuperación del estado nutricional del paciente. Posteriormente, no se registran otros ingresos hospitalarios, continúa asintomático respiratorio, con ganancia de peso y recuperación nutricional.

Conversion of traditional Chinese medicine (TCM) into nanomedicine:application of theory of unification of medicines and excipients / 中国中药杂志

In recent years, the use of active substances as excipients or as substitutes for other excipients in the design of modern drug delivery systems has received widespread attention, which has promoted the development of the theory of unification of medicines and excipients in the design of traditional Chinese medicine(TCM) preparations. Adopting the theory of unification of medicines and excipients to design drug delivery systems can reduce the use of excipients and thus the cost of preparations, reduce drug toxicity, increase drug solubility and biocompatibility, enhance synergistic effect, and realize targeted delivery and simultaneous delivery of multiple components. However, the research on the application of this theory in the modern drug delivery system of TCM preparations is still insufficient, with few relevant articles. In addition, the TCM active substances that can be used as the excipients remain to be catalogued. In this paper, we review the types and applications of the drug delivery systems with TCM active substances as excipients and describe their common construction methods and mechanisms, aiming to provide references for the in-depth research on the modern drug delivery systems for TCM preparations.

Advances in taste masking technology based on preparation technology / 药学学报

Good medicine tastes bitter, but it is often difficult to swallow because the drug is bitter and astringent, so that the compliance of patients with medication is poor. However, the use of taste masking technology can better improve this situation. Appropriate and effective taste masking technology can improve the drug compliance of patients, especially children, it can also improve the curative effect and the clinical value of drugs. Herein, we summarize the latest research progress of taste masking technology, and summarize the traditional taste masking technology from the aspects of action mechanisms and application scopes. Finally, the novel and efficient taste masking technologies were presented.

CHINA PH ARMACY Volume 33，Number 13，July 15，2022 Semimonthly Table of Contents Discussion on development difficulties and countermeasures of complex preparations in China / 中国药房

OBJECTIVE To discuss the difficulties in t he development of complex preparations and puts forward solutions ，in order to provide some reference for the development and preparation of complex preparations. METHODS Based on the development status of complex preparations ，the challenges faced by the development of complex preparations were analyzed ，and the countermeasures for the development of complex preparations were proposed. RESULTS & CONCLUSIONS The development of complex preparations required high quality of personnel ，and was limited by pharmaceutical excipients ，delivery devices and pharmaceutical equipment. The preparation process was complex ，there were many quality control parameters and patent barriers. Complex preparation development enterprises need to pay more attention to talents ，pharmaceutical excipients ，delivery devices and pharmaceutical equipment ，and clarify the impact of key technology on preparation production and quality characteristics ；in addition，they need to strengthen independent research and development ，crack the patent layout of original research enterprises and protect their own innovative achievements. Domestic complex preparation development enterprises can combine imitation and innovation to develop complex preparation products with independent brands to better meet the needs of patients.

Interpretation of the Guideline for Pharmaceutical Excipients of Animal Origin / 中国药科大学学报

@#Pharmaceutical excipients of animal origin, an important part in pharmaceutical excipients, are widely used in pharmaceutical preparations.However, compared with the pharmaceutical excipients of other origins, pharmaceutical excipients of animal origin have more special requirements in many aspects, such as raw materials, production, quality control, storage, supervision, etc.Chinese Pharmacopoeia 2020 first included the Guideline for Pharmaceutical Excipients of Animal Origin, which introduces the basic ideas and technical requirements for the life cycle quality control of pharmaceutical excipients of animal origin based on the risk management concept.This article illustrates the specificity of the pharmaceutical excipients of animal origin, and interprets the main contents of this guideline in conjunction with relevant domestic and foreign regulations and technical documents, thereby providing comprehensive reference for the implementation of the guideline.

Preparation of Angelica•Cinnamomum self•microemulsion drug delivery system based on the concept of “unifica- tion of drugs and excipients ” / 中国药房

OBJECTIVE To prepare Angelica•Cinnamomum（Angelica sinensis-Cinnamomum cassia ）self•microemulsion drug delivery system （AC•SMEDDS），and to optimize its formulation and characterize its preparation . METHODS Using Angelica• Cinnamomum mixed volatile oil as oil phase and model drug ，on the basis of selecting emulsifier and co -emulsifier and the optimization of their mass ratio range ，the formulation was optimized with central composite design •response surface methodology using the ratio of oil phase （Angelica•Cinnamomum mixed volatile oil ），mass ratio of emulsifier and co -emulsifier as factors ，the comprehensive score of volatile oil content ，particle size and emulsifying time as index . Morphology，particle size ，drug loading ， entrapped efficiency and stability of optimized AC•SMEDDS were characterized . RESULTS The optimum formulation of AC•SMEDDS contained the ratio of oil phase was 30%，and the mass ratio of emulsifier （EL•40）and co -emulsifier（ethanol）was 9∶1. Results of validation tests showed that the average particle size of AC•SMEDDS was （148.33±1.53）nm，and emulsifying time was （18.44±0.11）s. The comprehensive score was 0.68，relative deviation of which from the predicted value （0.70）was 2.86%. AC•SMEDDS prepared by optimal formulation was faint yellow ，uniform and transparent liquid ，and spherical particals with translucent edge were observed under transmission electron microscope . Calculated by ligustilide and cinnamaldehyde ，the drug loading was （7.58±0.03） and （4.17±0.01） mg/g，and entrapped efficiency was （93.25±0.01）% and （88.89±0.02）% ， respectively. No stratification or precipitation occurred after centrifugation at the speed of 10 000 r/min or placing within 7 （No.2019-0520） days at 4 and 25 ℃ . The contents of ligustilide and cinnamaldehyde were stable . Its particle size had no significant change after 50，100 and 200 times dilution by purified water . CONCLUTIONS AC•SMEDDS is prepared successfully and its formulation is optimized . The stability of the preparation is good .

Pharmaceutical evaluation of compounded furosemide capsules and excipient performance

Abstract Compounding pharmacies play an important role not only in compounding personalized formulations, but also preparing drugs at the same concentration and dosage as those from commercial manufacturers. The excipients used in compounding are generally standardized for many drugs, however they do not consider the intrinsic properties, such as the poor water solubility, of each substance. The excipient performance of commercially available compounded furosemide capsules in 7 compounding pharmacies from Manaus was evaluated and compared them to the performance of the reference medicinal product (Lasix® tablets) and 2 batches of capsules made in-house (T2 and T4) with a standardized excipient. All batches were subjected to tests for weight variation, assay, uniformity of dosage units, disintegration and dissolution profile. Of the 7 different compound formulas acquired in the compounding pharmacies, only 2 passed all tests. Most formulas passed the tests for weight determination, disintegration time and assay, however batches from 2 establishments failed in regards to the uniformity of the content and 5 batches failed the dissolution test. The reference medicinal product was approved in all tests, as were the T2 capsules made in-house with drug-excipient ratio 1:2. These results confirm the importance of the excipient composition, especially for poorly soluble drugs.

Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach

Abstract The purpose of this study is to optimize the composition of extragranular excipients (EGE) and mixing time of granules with EGE of paracetamol tablet formulation using Design of Experiments (DoE) approach. The effect of the composition of EGE and the mixing time of granules with EGE on granule and tableting properties of paracetamol tablet formulation was investigated using a combined model of mixture and process factors (Design-Expert 12). A total of 18 tablet formulations were manufactured by wet granulation using varying compositions of EGE and varying mixing time. Granule and tablet properties of each formulation were evaluated as response variables for the design, data generated were fitted into models and analysed to generate a design space that was used for optimization studies. The proposed EGE composition as predicted by the design was confirmed and validated after preparation and evaluation of the granule and tablet properties. The optimized composition for the EGE that yielded granules and tablets of desirable characteristics was found to be maize starch (5 %), talc (4.9 %) and magnesium stearate (0.1 %) with a mixing time of 2 min. The tablets produced with the optimized composition had better mechanical strength and disintegration time than the formulation prepared using an existing formula of maize starch (7.8 %), talc (2 %) and magnesium stearate (0.2 %) that were obtained using the One Variable at a Time (OVAT) approach. This study confirmed the relevance of quality by design in development of pharmaceutical formulations.

Spray Drying in Research of Traditional Chinese Medicine Powders： A Review / 中国实验方剂学杂志

After more than 100 years of development， spray drying technology has become more mature and widely used， and it is of great importance in the field of traditional Chinese medicine （TCM）. TCM powders prepared by spray drying is the raw material of dispensing granules， and the powder properties have an important influence on subsequent molding process and product quality. As a new form of TCM， dispensing granules have been included in the management category of TCM decoction pieces， indicating a broader application market， and a consensus has also been reached on the importance of TCM powder research. Based on this， the author summarized the application progress of spray drying in the study of TCM powders， including the factors affecting spray drying process， such as liquid properties， process parameters and equipment factors， as well as the application of computational fluid dynamics （CFD） and thermodynamic model in spray drying process simulation. Moreover， some commonly used pharmaceutical excipients for the modification of TCM powders were also introduced such as maltodextrin， microcrystalline cellulose and povidone. In addition， spray drying technology can also be used as a preparation technology for new drug delivery systems such as microcapsules and solid dispersions. Through the summary of this paper， the author suggests that the future research direction of spray drying of TCM can be carried out from the aspects of application rule of the coprocessing auxiliary materials based on the "unification of medicines and excipients"， the "structure-property" relationship of spray-dried powders and the application of computer simulation and design， so as to further enrich the application of spray drying in the field of TCM powders.

Modern Research of Nasal Preparations of Traditional Chinese Medicine： A Review / 中国实验方剂学杂志

Nasal preparations have unique advantages in drug delivery and are widely used in the treatment of local and systemic diseases. Nasal administration of traditional Chinese medicine （TCM） has a long history in China. In recent years， nasal preparations of TCM have attracted wide attention. Based on the information about nasal preparations of TCM from the database of National Medical Products Administration （NMPA）， Yaozh.com and China National Knowledge Internet （CNKI） in the recent 30 years， the formulation， the listed products， commonly used TCM， pharmaceutical excipients， clinical application and safety research of modern nasal preparations of TCM were summarized and expounded. Focusing on many problems in the development of modern nasal preparations of TCM， such as inaccurate dosage of some products， incomplete quality standard system of pharmaceutical excipients， imperfect safety evaluation， lack of research and development of nasal drug delivery devices and so on， the possible solutions and prospects were put forward from the aspects of optimizing the extraction and separation process of TCM， the quality control and application method of pharmaceutical excipients， the development of new dosage forms， the safety evaluation of nasal administration of TCM， and the design and development of nasal administration devices. The aim is to provide ideas for the development of nasal preparations of TCM and provide scientific basis for its sustainable utilization.

Historical Evolution and Modern Research Progress of Rehmanniae Radix / 中国实验方剂学杂志

Rehmanniae Radix is a common medicine of traditional Chinese medicine， which has the function of nourishing Yin and tonifying the kidney， and has a long application history of processing. This medicine was first recorded in Synopsis of Golden Chamber （《金匮要略》）， which was mainly produced by steaming and boiling. Its processing materials were diverse. In addition to rice wine， honey， Amomi Fructus， milk， Aquilariae Lignum Resinatum， and Carthami Flos were also recorded in ancient books， but with the evolution of time， the characteristic excipients gradually disappeared. Based on this， starting with different excipients， the author consulted the classics of materia medica and processing specifications in various regions， sorted out the historical evolution of Rehmanniae Radix processing， and explored new methods and new ideas to exert the maximum efficacy on this basis. At the same time， the effects of different processing excipients on the chemical components and pharmacodynamic effects of Rehmanniae Radix were analyzed. After literature review， it was found that Rehmanniae Radix mainly had the effects of clearing heat and cooling blood， nourishing Yin and generating fluid. Its traditional processing excipients generally used rice wine， Carthami Flos and others. After processing with different excipients， there was different effects on the chemical components and pharmacological effects of Rehmanniae Radix. In summary， this paper can provide useful reference for standardized research on different processed products of Rehmanniae Radix.

Comparison of UPLC Fingerprint and Determination of Index Components Before and After Processing of Cyperi Rhizoma Processed with Four Excipients / 中国实验方剂学杂志

Objective:To study the quality evaluation method of Cyperi Rhizoma processed with four excipients. Method:Ultra-performance liquid chromatography （UPLC） fingerprints of raw products and processed products with four excipients of Cyperi Rhizoma were established， and the changes of chemical components in the fingerprints before and after processing were compared by chemometric analysis. The mobile phase was consisted of methanol （A）-water （B） for gradient elution （0-10 min， 5%-40%A； 10-30 min， 40%-70%A； 30-40 min， 70%A） at a flow rate of 0.3 mL·min^-1. The injection volume was 3 μL， the column temperature was 35 ℃， and the detection wavelength was 280 nm. The content changes of main index components in Cyperi Rhizoma before and after processing were compared by UPLC. The mobile phase was methanol-water （75∶25） and the detection wavelength was 242 nm. Result:Processing with four excipients had a significant impact on the overall characteristics of chemical components in the fingerprint of Cyperi Rhizoma. A total of 28 characteristic peaks were identified in fingerprints of the raw and processed products. Among them， peaks 1， 2 and 4 were specific peaks of the processed products， peak 5 was characteristic peak of the raw products. Peak 2 was identified as 5-hydroxymethylfurfural， peak 24 as cyperenone and peak 27 as <italic>α</italic>-cyperone. The 5-hydroxymethylfurfural produced by the processing with four excipients came from rice vinegar， rice wine and Maillard reaction of polysaccharides in Cyperi Rhizoma. The results of determination showed that there was no significant difference in the content of cyperenone after processing， but the content of <italic>α</italic>-cyperone decreased significantly. Conclusion:In the process of Cyperi Rhizoma processed with four excipients， there are new components produced by structural transformation， which are accompanied by changes in the content of index components. In this study， the quality of raw and processed products of Cyperi Rhizoma can be rapidly and effectively evaluated from qualitative and quantitative aspects.

Comparison of UPLC Fingerprint and Determination of Main Components Before and After Processing of Artemisiae Argyi Folium Processed with Four Excipients / 中国实验方剂学杂志

Objective:To establish the ultra-performance liquid chromatography （UPLC） fingerprints of Artemisiae Argyi Folium and Artemisiae Argyi Folium processed with four excipients， and quantitatively analyze the 8 phenolic acids and flavonoids contained in them， in order to explore the quality evaluation method of Artemisiae Argyi Folium processed with four excipients. Method:UPLC was used with Shim-pack XR-ODS C₁₈ column （2.0 mm×75 mm， 2.2 µm）， mobile phase of acetonitrile （A） -0.2% formic acid aqueous solution （B） for gradient elution （0-1 min， 10%A； 1-2 min， 10%-15%A； 2-17 min， 15%-18%A； 17-24 min， 18%-28%A； 24-36 min， 28%-38%A； 36-41 min， 38%-60%A； 41-45 min， 60%-100%A）， detection wavelength of 330 nm and flow rate of 0.2 mL·min^-1. The UPLC fingerprints of Artemisiae Argyi Folium before and after processing were established， and analyzed by chemometrics. Contents of 5-caffeoylquinic acid， 3-caffeoylquinic acid， 4-caffeoylquinic acid， 3，4-dicaffeoylquinic acid， 3，5-dicaffeoylquinic acid， 4，5-dicaffeoylquinic acid， jaceosidin and epuatilin in the decoction pieces were determined. Result:The fingerprints of Artemisiae Argyi Folium before and after processing were established， and the UPLC characteristic chromatograms of Artemisiae Argyi Folium before and after processing had good consistency， and the similarity was >0.94. Compared with Artemisiae Argyi Folium， the contents of 3-caffeoylquinic acid and 3，4-dicaffeoylquinic acid had no significant change after processing， the contents of jaceosidin and epuatilin decreased after processing， while the contents of 5-caffeoylquinic acid， 4-caffeoylquinic acid and 4，5-dicaffeoylquinic acid increased significantly （<italic>P<</italic>0.01）， their average increasing rates were 32.50%， 66.83%， 29.39%， respectively. And content of 3，5-dicaffeoylquinic acid was significantly decreased （<italic>P<</italic>0.01） ， and the average reduction rate was 51.25%. Conclusion:The contents of chemical components in Artemisiae Argyi Folium and Artemisiae Argyi Folium processed with four excipients have changed to a certain extent. Among them， 5-caffeoylquinic acid， 3，5-dicaffeoylquinic acid， 4-caffeoylquinic acid and 4，5-dicaffeoylquinic acid can be used as the key indicators for quality evaluation of Artemisiae Argyi Folium before and after processing.

Effect of paracellular permeation enhancers on intestinal permeability of two peptide drugs, enalaprilat and hexarelin, in rats

Transcellular permeation enhancers are known to increase the intestinal permeability of enalaprilat, a 349 Da peptide, but not hexarelin (887 Da). The primary aim of this paper was to investigate if paracellular permeability enhancers affected the intestinal permeation of the two peptides. This was investigated using the rat single-pass intestinal perfusion model with concomitant blood sampling. These luminal compositions included two paracellular permeation enhancers, chitosan (5 mg/mL) and ethylenediaminetetraacetate (EDTA, 1 and 5 mg/mL), as well as low luminal tonicity (100 mOsm) with or without lidocaine. Effects were evaluated by the change in lumen-to-blood permeability of hexarelin and enalaprilat, and the blood-to-lumen clearance of

Progress in application of Bletilla striata polysaccharide in novel drug delivery systems and biomaterials / 中国中药杂志

As the main active ingredient of the orchidaceous herb Bletilla striata, B. striata polysaccharide(BSP) has pharmacological activities such as promoting coagulation, anti-inflammation, anti-oxidation, promoting wound healing, anti-tumor, and immunomodulation, and is biodegradable and non-toxic. Additionally, it has the material properties of suspension thickening, film-forming adhesion, coating and solubilizing, targeting and slow releasing, effect-enhancing and toxicity-reducing, etc., playing the role of unification of medicines and excipients. Therefore, BSP has a wide application prospect in the fields of drug delivery system and trauma repair. This paper reviews the research progress of BSP application in new drug delivery systems and biomaterials based on the related li-terature in recent years, with the aim of providing reference for the further research and application of BSP.

Preparation of personalized traditional Chinese medicine condensed water pill without excipients based on correlation between concentrate viscosity and molding quality / 中国中药杂志

To explore the correlation between concentrate viscosity and molding quality of personalized traditional Chinese medicine(TCM) condensed water pill, this study established a concentrate viscosity characterization method with rotational rheometry. Seven model prescriptions were respectively concentrated to different degrees and the viscosity of each concentrate was determined. The pre-sence of 'viscosity jump' in the middle stage of 'flag hanging' of all the model prescriptions implied that there might be an ideal viscosity range in the preparation of condensed water pill. The further study of 22 model prescriptions demonstrated that the optimum viscosity range of concentrate was 5-15 Pa·s(25 ℃) for approximately 82% of the prescriptions. About 18% of the prescriptions had a wide range, which might be caused by the high proportions of mineral and crustacean drugs in the crushing part and sugar and fibrous drugs in the decocting part. This study clarified the optimum viscosity range for concentrates of personalized TCM condensed water pills and achieved a preparation technology without any excipient, laying a foundation for the on-line control of the preparation.

Exploratory study on preparation of high drug loading granules with traditional Chinese medicine raw powder as carriers / 中国中药杂志

With Sangtang Yin granule as model drug,and based on the strategy of " unification of medicines and excipients",the feasibility of preparing high drug loading granules with traditional Chinese medicine( TCM) raw powder as carrier was explored. The powder yield,particle size and particle size distribution,fillibility,flowability,hygroscopicity,reconstituability and other key physical properties relating to preparations of 8 herbs( Dioscoreae Rhizoma,Euryales Semen,Atractylodis Macrocephalae Rhizoma,Coicis semen,Poria,Puerariae Lobatae Radix,Puerariae Thomsonii Radix and Coicis Semen by stir-frying with bran) were studied after being smashed,and the feasibility of taking them as excipients of TCM granules was evaluated by co-spray drying,dry granulation and other preparation techniques. According to the results of the physical properties of raw powders,raw powders of Dioscoreae Rhizoma,Euryales Semen and Puerariae Thomsonii Radix had a high powder yield,uniform particle size distribution,good fillibility,poor hygroscopicity and good reconstitutability,with the feature of assisting granule forming. Compared with the prescription of spray dry powder Sangtang Yin without any excipient,the co-sprayed powder had a high yield,good fillibility and compressibility. The yield of dry granules prepared by co-spraying dry powder was increased by more than 10%,and the particles had a uniform color,good fluidity and dissolubility with the drug-loading rate up to 100%. Based on the physical characteristics of TCM raw powder combined with the analysis of the preparation process,Dioscoreae Rhizoma and Puerariae Thomsonii Radix raw powder were selected as the carriers of granule preparations,and Sangtang Yin granule without any excipient was successfully prepared. The findings provide a feasible idea for the preparation of TCM granules with a high drug loading capacity.

Advances in research on pediatric oral liquid dosage forms / 中国药科大学学报

@#Liquid preparations are the commonly used oral dosage forms in pediatric clinical practice.This review introduces the pediatric oral liquid dosage forms including extemporaneous preparation of oral liquid formulations, oral liquid sustained and controlled release formulations, nanosuspensions, nanoemulsions, self-nanoemulsions and milk-based liquid formulations.In addition, the efficient flavoring and taste masking technologies, using safe pharmaceutical excipients, high-demanding technical standards and verification strategies, establishing excellent workflow management systems can contribute to the development and application of pediatric oral liquid dosage forms which are safer, more effective and better compliant.This review is helpful in laying the relevant theoretical foundation for further studies on pediatric oral liquid dosage forms.

Formulation And Evaluation Of Orodispersible Tablets Of Lamotrigineusing Discrete Super Disintegrants And Coprocessed Excipients

Objective: The present study was designed to formulate and evaluate the orodispersible tablets of lamotrigine after enhancing its solubility. Methods: Lamotrigine was made into an inclusion complex with eudragit E 100 my kneading and mass extrusion method and later this mixture is compressed into orodispersible tablet using various super disintegrants and co-processed excipients to reduce the disintegration time for providing prompt action through rapid drug release. Results: Lamotrigine ODTs containing F-melt (F1-3%, F2-5%) dispersed in lesser time of (9±0.11) and (21±0.58) compared to formulations with polyplasdone XL-10 and primellose as super disintegrants respectively with F1 showing short wetting time. The water absorption was also was found to be more for formulation with 3% F-Melt. Conclusion: Lamotrigine orodispersible tablets were prepared by direct compression technique by using 3% and 5% of three super disintegrants (f-melt, primellose and polyplasdone XL-10). Disintegration time of F1 (3% f-melt) formulation was found to be least (7 sec).

Effects of pharmaceutical excipients on CYP3A activity and its guiding effects on quality and efficacy consistency evaluation of generic drugs / 中国临床药理学与治疗学

The prescription and technology of pharmaceutical preparations are the basis for ensuring the quality and efficacy of medicines. Pharmaceutical excipients are important part of pharmaceutical preparations. As it's known to all that some pharmaceutical excipients can affect the activity of CYP3A, and then may influence the metabolism and bioavailability of its substrates in vivo. Relative bioavailability is a key element of generic drug research in China and the United States. Our country is advancing the quality and efficacy consistency evaluation of generic drugs. Therefore, it is of great practical significance to understand the impact of pharmaceutical excipients on CYP3A and its guiding role in consistency evaluation.